4. Results of recent file reviews noted that there is a lack of clarity in patientinformed consents regarding expense reimbursement and study stipends. Expenses should be noted separately as they are not taxable.

5. Results of recent reviews demonstrate the need to be aware: If a sponsor representative is required to be present during the treatment of a study subject in any specific treatment area (i.e., operating room or cath lab) for the research project, the informed consent must include this information.